Recommendation on management and assessment of periodic safety update reports (PSURs) of veterinary medicinal products

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Current effective versionAdopted recommendation
Reference numberEMEA/CVMP/PhVWP/4550/2006
Published21/10/2008
Effective from01/01/2009
KeywordsVeterinary medicinal product, safety, pharmacovigilance, suspected adverse reaction (SAR), suspected lack of efficacy, periodic safety update report (PSUR), assessment, competent authority.
Description

This recommendation aims to facilitate assessors' scientific and regulatory assessment of PSURs, and the standardisation of the format of PSUR Assessment Reports (AR) across the EU, regardless of the marketing authorisation procedure. The objective of this harmonisation is to ensure that PSUR ARs are of high quality and contain necessary information in a well-organised format.

The recommendation is addressed to national competent authority assessors of PSURs.


Document history

Current version

Adopted recommendation

 

Overview of comments

 

Concept paper

Published: 21/10/2008

 

Published: 21/10/2008

 

Published: 13/07/2005


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